USPTO Patents Application 09937848

S/N 09/937,848

Page 7

REMARKS

Upon entry of the amendments, claims 59-93 are canceled and
claims 94-113 are added to more clearly define Applicants'
invention. The amendments do not introduce any new matter within
the meaning of 35 U.S.C. §132. Accordingly, entry of the
amendments is respectfully requested.

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1. Claim Obiections

In the Office Action, the Examiner states:

Claims 61 and 62 are duplicates of each other. The Examiner
respectfully requests that one of these claims be cancelled or
amended to distinguish them.

The term "intercellular" is spelled incorrectly in claim 60.

Applicants have canceled claims 60, 61 and 62 and thus
obviating grounds for this objection. Further, Applicants
respectfully point out that newly added claim 96 is directed to the
promotion of the formation of connexin, while new claim 97 is
directed to the promotion of the formation of connexin 43 .
Therefore, claims 96 and 97 are not redundant.

In view of the foregoing. Applicants respectfully request the
Examiner to withdraw the claim objections.

2. Rejection Under 35 U.S.C. §112, first paragraph

Claims 79-93 are rejected under 35 U.S.C. §112, first
paragraph, as failing to comply with the enablement requirement.
In the Office Action, the Examiner states:

The claim(s) contains subject matter which was not described in the
specification in such a way as to enable one skilled in the art to
which it pertains, or with which it is most nearly connected, to
make and/or use the invention...

(1) The nature of the invention:

The invention is directed toward a method of promoting and/or
increasing the activity of a cosmetic agent acting directly in the
cell or via intracellular second messengers, comprising the
application of a cosmetic agent to the skin areas of a person in
need thereof, of an effective amount of at least one substance
promoting intercellular communication.

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(2) The state of the prior art:

The prior art is filled with cosmetic agents which promote
intercellular communication, as most transdermally applied cosmetic
agents are absorbed by the epidermis and other layers of skin and
then transported across veins and arteries (blood vessel wall cells)
in the blood stream or are absorbed by the epidermis which affects
the dermis and other skin layers. For example see US 5,811,083
which teaches a topically applied composition that has its effects
on the dermis, though the topical application occurs on the
epidermis. However, the art is silent in regard to agents, whose
activity is increased or promoted by being used in conjunction with
active compounds that promote intercellular communication.

(3) The relative skill of those in the art:

The relative skill of those in the art is high, as one of
skill cannot predict how one compound will affect another compound
or a physiological process when applied to the skin of a live
person .

(4) The predictability or unpredictability of the art:

The unpredicatability of the cosmetic art is very high, as it
is impossible to know how two or more chemical compounds will behave
in vivo and how their composition will affect one another and an in
vivo physiological process.

(5) The breadth of the claims:

The claims are very broad. The cosmetic agent can be anything
and the substance promoting intercellular communication encompasses
an incredible number of compounds because, as described above, most
every topically applied cosmetic agent promotes intercellular
communication .

(6) The amount of direction or guidance presented

The instant specification provides no guidance or direction as
to what these cosmetic agents are or can be. The method is merely
stated .

(7) The presence or absence of working examples:

The instant specification provides no working examples of the
method of claim 79.

(8) The quantity of experimentation necessary:

Since it is impossible to predict the physiological effect of
bringing two chemical compounds together, an incredible amount of
experimentation would be required to determine what cosmetic agents
and what substances can be combined to produced an increase in the
activity/effect of the cosmetic agent.

Applicants have canceled claims 79-93,
grounds for this rejection. Therefore^
respectfully asked to reconsider and withdraw

and thus obviating
the Examiner is
this rejection.

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3. Rejection Under 35 U,S.C. §112, second paragraph

Claims 59-78 and 91 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite. In the Office Action, the Examiner
states :

(i) The phrase "for obtaining an anti-ageing effect on said skin
areas, for improving the firmness and elasticity of the skin, for
delaying the appearance of wrinkles or for reducing their depth" in
claim 59 {lines 3-6) is vague and indefinite, as it is confusing.
Are not improving firmness and elasticity of the skin and delaying
the appearance of wrinkles and reducing their depth, anti-ageing
effects? Is Applicant claiming a range within a range?

(ii) The phrase "said substance is presenting cosmetic composition"
in claim 64 is vague and indefinite, as it is confusing. What does
this phrase mean?

(iii) Claim 71 recites the limitation "the composition of claim 65"
in line 1. There is insufficient antecedent basis for this
limitation in the claim.

(iv) Claim 76 and 91 are vague and indefinite, as the scope of the
claims is unascertainable . How can the conditions both comprise and
consist essentially of? This is confusing.

Applicants have canceled claims 59-78 and 91 and thus
obviating grounds for this rejection. Therefore, Applicants
respectfully request the Examiner to reconsider and withdraw this
rejection .

4. Rejection of Under 35 U.S.C. §102 (b)

Claim 59 is rejected under 35 U.S.C. §102 (b) as being
anticipated by Pelle et al., U.S. 5,811,083. In the Office Action,
the Examiner states:

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Pelle et al. disclose in Col. 13, line 14-Col. 14, line 6, a method
for treating or retarding lipid peroxidation-medicated skin aging in
a patient which comprises topically administering to skin of a
patient in need thereof a composition comprising a lipid
peroxidation inhibiting amount of a tocopherol derivative. Col. 2,
lines 36-37, teach the tocopherol derivative of Col. 13-14, as a
novel tocopherol compound with enhanced antioxidant activity.

Applicants respectfully traverse this rejection. The test for
anticipation is whether each and every element as set forth in the
claims of the application at issue is found, either expressly or
inherently described, in a single prior art reference. Verdegaal
Bros, V. Union Oil Co. of California, 2 U.S.P.Q.2d 1051, 1053 (Fed,
Cir. 1987); MPEP §2131. The identical invention must be shown in
as complete detail as is contained in the claim. Richardson v.
Suzuki Motor Co., 9 U.S.P.Q,2d 1913, 1920 (Fed. Cir. 1989); MPEP
§2131. Furthermore, the elements must be arranged as required by
the claim. In re Bond, 15 U.S.P.Q.2d 1566 (Fed. Cir. 1990).

Applicants have canceled claim 59 and added new claim 94 in
order to more clearly define the present invention. Applicants
respectfully state that Pelle et al. do not teach a method for
promoting intercellular communication as presently claimed.
Intercellular communication has nothing to do with the classical
means, which are used to improve transdermal penetration of a
substance. Among the classical vectors for improving

intracutaneous or percutaneous penetration, alcohol is the most
well known in the art. It is known that such vectors enable
substances to cross the barrier constituting the upper layers of

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the skin. Such a mechanism is completely different from the new
method according to the present invention, which enables the
improvement or restoration of intercellular communication,
especially via the gap junction. See specification pages 2-3, and
example III.

Accordingly, each and every element of the present invention
is not taught in the cited reference, and Applicants respectfully
request the Examiner to reconsider and withdraw the rejection.

5. Rejection of Under 35 U.S.C. §103 (a)

Claims 59-93 are rejected under 35 U.S.C. §103 (a) as being
unpatentable over Briand (English Translation of FR 2,657,012) in
view of Winget, U.S. Patent No. 5,767,095. In the Office Action,
the Examiner states:

The instant invention is directed toward a method of skin care
comprising applying to skin areas of a person in need thereof, an
effective amount of at least one substance promoting intercellular
communication for obtaining an anti-ageing effect, improving
firmness and elasticity of skin, delaying the appearance of
wrinkles, or reducing their depth, and a method of promoting and/or
increasing the activity of a cosmetic agent acting directly in the
cell or via intracellular second messengers, comprising the
application of a cosmetic agent to the skin areas of a person in
need thereof, of an effective amount of at least one substance
promoting intercellular communication.

Briand teaches the use of microscopic alagae extracts for the
preparation of cosmetics, wherein the extracts have free radical
reducing activity, wherein a decrease in free radical production is
established in the art to reduce aging, see page 2. Skeletonema is
specifically taught as a preferred extract, see page 3. The
cosmetics are taught as compositions comprising algae extracts and
additional cosmetic ingredients/agents for treating the skin, see
page 12. External application is specifically taught, see page 12.
Exemplified is a composition comprising 3% extract of Skeletonema.
Briand does not teach Skeletonema as a complete lipid extract, as

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water and an organic solvent art (ethanol and isopropanol) are
taught as the extraction medium for Skeletonema.

Winget teaches anti-inflammatory compositions containing a purified
microalgal lipid preparation for application to the skin.
Skeletonema is specifically taught as a preferred algae. Such
extracts are taught as imparting potent anti-inflammatory effects to
the skin of a user. See Col. 1, line 19-Col. 2, line 55; Col. 10,
lines 9-66.

It would have been obvious to one of ordinary skill in the art at
the time the invention was made to incorporate a lipid extract of
Skeletonema into the composition of Briand or to teach the extracts
of Briand as lipid extracts, as taught by Winget, because of the
expectation of achieving a product that treats existing skin aging
and protects again further skin aging by UV damage (effect of
antiinflammatories) .

Since a compound and its properties are inseparable, the Skeletonema
of the combined references have the properties of promoting
intercellular communication via gap junctions of keratinocytes ,
fibroblasts and skin preadipocytes and of promoting intercellular
communication to promote the formation of connexin.

The claims are directed to a method of applying a composition
comprising an extract of Skeletonema to the skin. Any properties
exhibited by or benefits provided the composition are inherent and
are not given patentable weight over the prior art. A chemical
composition and its properties are inseparable. Therefore, if the
prior art teaches the identical chemical structure, the properties
Applicant discloses and/or claims are necessarily present. In re
Spada, 911 F.2d 705, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP
2112.01. The burden is shifted to Applicant to show that the prior
art product does not inherently possess the same properties as
instantly claimed product. The prior art teaches application to the
skin of compositions containing the same components as instantly
claimed, which would inherently treat aging or promote the activity
of a cosmetic agent, as instantly claimed. Applicant has not
provided any evidence of record to show that the prior art
compositions do not exhibit the same properties as instantly
claimed.

The Examiner respectfully points out instant claims 63, 65-76, 80-91
are product-by-process claim. Even though product-by-process claims
are limited by and defined by the process, determination of
patentability is based on the product itself. The patentability of
a product does not depend on its method of production. If the
product in the product-by-process claims is the same as or obvious
from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different process. In re
Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See
MPEP 2113.

Regarding claims 76 and 91, it is respectfully pointed out that for
the purposes of searching for and applying prior art under 35 USC
102 and 103, absent a clear indication in the specification or

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claims of what the basic and novel characteristics actually are,
"consisting essentially of" will be construed as equivalent to
comprising. If an applicant contends that additional steps or
material in the prior art are excluded by the recitation of
"consisting essentially of", applicant has the burden of showing
that the introduction of additional steps or components would
materially change the characteristics of applicant's invention. See
MPEP 2111.03.

Applicants respectfully traverse this rejection. To establish
a prima facie case, the PTO must satisfy three requirements.
First, the prior art relied upon, coupled with the knowledge
generally available in the art at the time of the invention, must
contain some suggestion or incentive that would have motivated the
skilled artisan to modify a reference. In re Fine, 837 F.2d 1071,
1074, 5 U,S.P.Q.2d 1596, 1598 (Fed. Cir. 1988). Second, the
proposed modification of the prior art must have had a reasonable
expectation of success, determined from the vantage point of the
skilled artisan at the time the invention was made. Amgen, Inc. v.
Chugai Pharm. Co., 927 F.2d 1200, 1209, 18 U.S.P.Q.2d 1016, 1023
(Fed. Cir. 1991) . Lastly, the prior art reference must teach or
suggest all the limitations of the claims. In re Wilson, 424 F.2d
1382, 1385, 165 U.S.P.Q. 494, 496 (C.C.P.A. 1970).
a. The present invention.

The present invention, as currently amended, is directed to a
method for promoting intercellular communication of skin cells,
comprising the application, to the appropriate skin areas of a
person in need thereof, of an effective amount of at least one

S/N

09/937,848

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lipid extract of the alga Skeletonema.

b. Cited references.

Briand discloses the use of microscopic algal extracts for the
preparation of pharmaceutical, cosmetic, feed or agricultural
compositions ,

Winget discloses pharmaceutical compositions of anti-
inflammatory microalgal lipid preparations containing
monogalactosyl dieicosapentaenoyl glycerol and processes for making
said preparations.

c. Differences between present invention and the cited references.

Applicants respectfully submit that none of the references,
either alone or in combination, teach, or suggest, a means for
promoting interconnection of skin cells, or intercellular
communication of skin cells, as is presently claimed. The
references do not contain any suggestion or motivation that they be
combined in the manner suggested in the Office Action.

Therefore, Applicants respectfully request the Examiner to
reconsider and withdraw the rejection.

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CONCLUSION

Based upon the above amendments and remarks, the presently
claimed subject matter is believed to be novel and patentably
distinguishable over the references of record. The Examiner is
therefore respectfully requested to reconsider and withdraw the
objection and rejections and allow all presently pending claims.
Favorable action with an early allowance of the claims pending in
this application is earnestly solicited.

Date: March , 2004
NATH & ASSOCIATES PLLC

1030 IS^'' Street N.W., 6'^'^ Floor
Washington, D.C. 20005
(202) 775-8383

GMN/TEH:ayd

By:

Respectfully submitted,
NATH & ASSOCIATES PLLC

Gary

Registration No. 26,955
Tanya E. Harkins
Registration No. 52,993
Customer No. 20529